CapSureFix Novus MRI™ SureScan™
FDA UDIEUDAMEDClass III (US FDA UDI)
Identity
- Trade Name
- CapSureFix Novus MRI™ SureScan™ EUDAMEDFDA UDI
- Generic Name
- Endocardial/interventricular septal pacing lead FDA UDI
- Device Name
- CapSureFix Novus Lead EUDAMEDLEAD 5076-58 MRI US RCMCRD FDA UDI
- Model / Reference
- 407685 EUDAMED5076-58 FDA UDI
- Description
- LEAD 5076-58 MRI US RCMCRD FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169708280 EUDAMED00763000014704 FDA UDI
- Basic UDI-DI
- B-00643169708280 EUDAMED
- PMA Number
- P930039 FDA UDI
- FDA Product Code
- NVN FDA UDIDTB FDA UDINVY FDA UDI
- EMDN Code
- J0190010102 ENDOCARDIAL ATRIAL AND VENTRICULAR LEADS, BIPOLAR (WITH ACTIVE OR PASSIVE FIXATION) EUDAMED
- GMDN Term
- Endocardial/interventricular septal pacing lead FDA UDI
Classification
- Device Class
- Class AIMDD EUDAMEDClass III FDA UDI
- Regulation Number
- 870.3680 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
Yes
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
Yes
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Dimensions & Sizes
- Size
- Length — 58.0 Centimeter FDA UDI
Category: Endocardial/interventricular septal pacing lead
CapSureFix Novus MRI™ SureScan™ by Medtronic, Inc. — Class III — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
P930039 also covers:
- CapSureFix Novus MRI™ SureScan® — MEDTRONIC, INC.
- CapSureFix Novus MRI™ SureScan® — MEDTRONIC, INC.
- CapSureFix Novus MRI™ SureScan® — MEDTRONIC, INC.
- CapSureFix Novus MRI™ SureScan® — MEDTRONIC, INC.
- CapSureFix Novus MRI™ SureScan® — MEDTRONIC, INC.
- CapSureFix Novus MRI™ SureScan® — MEDTRONIC, INC.
- CapSureFix Novus MRI™ SureScan® — MEDTRONIC, INC.
- CapSureFix Novus MRI™ SureScan™ — MEDTRONIC, INC.
- CapSureFix Novus MRI™ SureScan™ — MEDTRONIC, INC.
- CapSureFix Novus MRI™ SureScan™ — MEDTRONIC, INC.
- CapSureFix Novus MRI™ SureScan™ — MEDTRONIC, INC.
- CapSureFix Novus MRI™ SureScan™ — MEDTRONIC, INC.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class III | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Medtronic, Inc.
Sources (2)
- FDA UDI b5fa737e-b531-400c-922a-64754d30b71d 37 fields · synced Sep 17, 2026
- EUDAMED 58d5c83c-e3fd-4798-b9a1-c7e1fda7ae57 61 fields · synced Sep 17, 2026